UDI Resources
Seminar - UDI Beyond the Basics - A Masterclass on the Evolution of UDI
This Seminar will highlight the state of urgency in the industry, address implementation challenges - plus maximize the ROI of your UDI implementation in the future, ensuring it continues to drive business value.
Agenda
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Why UDI?
What devices need to be marked?
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Defining Medical DevicesIn the US, medical devices are sorted into three risk-based classes, defined by the intended use of the device and on indications for use.
Class I Class I devices do not support or sustain life, and include items such as tongue depressors, crutches or canes, and hand-held surgical instruments. Class II Class II devices require more specialized controls than Class I devices, but can be used without causing injury or harm to patient or user. Class II devices include blood pressure cuffs, oximeters, and diagnostic x-ray systems. Class III Class III devices support or sustain life, or are integral to the prevention and or treatment of illness or injury, requiring significant controls to ensure safety. They include items such as prosthetic joint implants, cardiac pacemakers, and HIV diagnostic tests.
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Timelines
The FDA published the Final Rule in September, 2013
Class III
Class III
- UDI on label & package: 1 year from Rule, 9/14
- GUDID Interface: 1 year from Rule, 9/14
- Direct part marking: 2 years from Rule if implantable, 9/15
- Direct part marking: 3 years from Rule, 9/16 if the device is:
- Intended to be used more than once and intended to be sterilized before each use
- Stand-alone software regulated as a medical device
- UDI on labels: 2 years from Rule
- GUDID Interface: 2 years from Rule
- Direct part marking: 2 years from Rule if implantable
- UDI on label and package, 3 years from Rule
- GUDID Interface, 3 years from Rule
- Direct part marking, 2 years from Rule if implantable, 5 years from Rule if the device is:
- A device intended to be used more than once and intended to be sterilized before each use, or
- A stand-alone software regulated as a medical device
- UDI on labels, 5 years from Rule for class I medical devices and devices that have not been classified into Class I, Class II, or Class III
- GUDID Interface, 5 years from Rule, data for Class I, devices and devices that have not been classified into Class I, Class II, or Class III.
- Direct part marking, 7 years from Rule Class I, devices and devices that have not been classified into Class I, Class II, or Class III required to be labeled with a UDI permanent mark.